BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2911522 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16352
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) UNDERWENT A PROCEDURE WHERE A BOVEE WAS USED. THE BOVEE WAS OVERSENSED AND LEAD TO PACING INHIBITION OF AN UNKNOWN DURATION. THE LOCAL BOSTON SCIENTIFIC WAS NOT AWARE OF ANY ADDITIONAL INFORMATION RELATED TO THIS CLINICAL OBSERVATION. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17140 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR N118| 5076| H219| 4543| 6949| 0185| 4518| 4402| 4524